Study of Multispectral Near-Infrared Imaging Using the MIMOSA Pro to Compare Tissue Oxygen Levels with Standard Vascular Tests in Adults with Vascular Disease or Leg Wounds

What this Trial Is About

This research aims to evaluate whether tissue oxygenation measurements obtained from the MIMOSA Pro multispectral near-infrared imaging device correspond to standard vascular assessment tools used in patients undergoing lower extremity vascular evaluations. It focuses on patients with peripheral vascular disease and chronic wounds of the lower limb. The study will explore correlations between MIMOSA Pro measures and clinical tests like the ankle-brachial index, toe-brachial index, transcutaneous oximetry, and Doppler waveforms, and how these relate to disease classifications and wound stages. Participants will continue with their usual vascular assessments including ankle-brachial index exams and other standard tests. They will also have additional imaging of their legs using the MIMOSA Pro device, which is non-interventional and used as an adjunct tool in the wound center. The study does not use MIMOSA device data to make clinical decisions. Participants will be followed for about two months during their regular visits. Throughout the study, investigators will assess participants vascular and wound status while collecting standard diagnostic data and MIMOSA Pro imaging results. The primary outcome is the correlation between MIMOSA oxygenation measures and standard vascular tools from baseline to the end of study. Secondary outcomes include correlation between MIMOSA measures and disease or wound severity. The study aims to understand the potential clinical utility of MIMOSA Pro imaging during standard care and involves no additional treatments or interventions beyond imaging and assessments.

Correlating Multispectral Near-Infrared Imaging to Standard Vascular Diagnostics